【摘要】 目的建立复方制剂银杏活脑胶囊的高效液相色谱（HPLC）指纹图谱,控制制剂质量。方法采用Inertsil ODS-SP C₁₈色谱柱（4.6 mm×250 mm,5μm）,流动相为甲醇-0.1%磷酸溶液,梯度洗脱,流速1 mL·min^-1,柱温25～30℃,检测波长为254 nm,建立指纹图谱;运用"中药色谱指纹图谱相似度评价系统"对6批制剂进行相似度评价,通过对比对照品的保留时间明确主要特征峰化学成分,并初步确定其中药材归属。结果建立了专属性、精密度、重复性和稳定性均良好的银杏活脑胶囊HPLC指纹图谱,6批制剂的指纹图谱相似度为0.894～0.940,确定共有峰为33个,共有9个主要特征峰得到明确的化学指认。结论所建立的银杏活脑胶囊的指纹图谱方法可行,可纳入该方质量评价系统的一部分,为银杏活脑胶囊的进一步研究提供参考。更多还原

【Abstract】 Objective To establish the HPLC fingerprint of Yinxing-Huonao capsule for quality control. Methods Inertsil ODS-SP C₁₈ column（250 mm×4.6 mm, 5 μm） was utilized to establish the fingerprint with the mobile phase comprising methanol-0.1% phosphoric acid at the flow rate of 1 mL·min^-1 in a gradient elution manner. The detection wavelength was set at 254 nm and the column temperature was maintained between 25℃ and 30℃. Similarity for 6 sets of samples was analyzed by the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine. The chemical components of the main characteristic peaks in the HPLC fingerprint of the Yinxing-Huonao capsule were identified by comparing the retention times of the reference substance, and the attribution of Chinese herbal medicines was preliminarily determined. Results The HPLC fingerprint of the Yinxing-Huonao capsule with good specificity, precision, repeatability, and stability was established. The similarity of six batches of preparations was 0.894-0.940.Thirty-three characteristic peaks were identified as common chromatographic peaks and nine of them were chemically identified. Conclusion The established HPLC fingerprint method of the Yinxing-Huonao capsule is feasible and can be included in the quality evaluation system of this prescription. The results of this research provided a reference for further research on the Yinxing-Huonao capsule.更多还原